The present invention relates to a device for the insertion and fixation of an intrauterine contraceptive device (IUD) to the uterine fundus of a female in the immediate post-partum or post-abortal period.
For many years, numerous studies have been done on the possibility of immediate post-partum insertion of IUDs. This method offers many advantages, especially in the developing world which faces overpopulation. The method of immediate post-partum insertion is of high interest in these countries because a high proportion of pregnant women deliver in a hospital setting mostly on an out-patient basis. So, the method reaches a large number of motivated women, confers protection before resumption of sexual activity and ovulation, is easily inserted without the slightest pain, does not interfere with lactation and the financial burden is small.
Unfortunately, the few reported experiences of immediate post-partum insertion, in which several models of IUDs have been used, lead to rather disappointing results because of a high rate of expulsion mainly during the first three months. The rate of translocation after insertion of the IUD has not been mentioned in these studies, but is most probably higher than the expulsion rate. Translocation of an IUD not only hinders its efficiency but can also damage the uterus, and thus be dangerous for the health of the woman.
A method of fixing the IUD in the uterine wall has been proposed in two patents namely in U.S. Pat. No. 3,598,115 and U.S. Pat. No. 3,954,103.
The first of these documents, U.S. Pat. No. 3,598,115, discloses a conventional device for the insertion of a special IUD into the uterine cavity. The IUD is provided with a retaining member, which is of sufficient rigidity to penetrate the uterine muscle under the action exerted on the back portion of the IUD. Such a rigid connection between the IUD and its retaining member is not desired because slight translocations of the IUD could harm the uterine wall and cause bleeding and pain. On the other hand, problems may also result during the involution of the post-partum uterus when the IUD has not been affixed in the central part of the uterine fundus.
The second document U.S. Pat. No. 3,954,103 and corresponding West German Pat. No. DE-2,505,941, describes an apparatus for the insertion and fixation of an IUD in the post-partum uterus, which is provided with a thread and a hook for the fixation of the IUD in the uterine wall.
This device consists of an outer cylindrical guide and an inner cylindrical member provided, on its front portion, with a needle on which a removable hook is attached. The IUD is placed between the outer and the inner cylinders. Outer and inner cylinders are temporarily interlocked. The needle and hook, attached to the inner cylinder, is partially covered by the outer cylinder.
The inner cylindrical member fits on the surgeon's finger for manual insertion into the uterus. The unlocking of the two cylinders is assured by manual force as the guide frontal portion engages the uterine wall. This manoeuvre is followed by the penetration of te needle in the uterine muscle. The needle and cylindrical members are then removed, leaving the hook, affixed to the IUD by a strap, in place.
This device is unpractical in use, due to the need for the introduction of the surgeon's finger or hand in the uterine cavity. This not only causes discomfort to the patient, but most of all this manoeuvre becomes almost impossible when the uterus is well contracted, which needed for an appropriate fixation of the retaining member in the wall of the uterine fundus. Moreover, insertion after abortion is impossible due to the too large diameter of the instrument. Also, no means have been provided for avoiding accidental disengagement of the retaining member from the needle before penetration of the needle in the uterine muscle, in which case the utility of the intervention would be completely lost. Finally, the traction of the thread ensures the extraction of the IUD from the device. This force could cause the retaining hook to be pulled out the uterine muscle.